RecruitingNot ApplicableNCT06353594

Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)


Sponsor

Jorge Sanz Sanchez

Enrollment

1,272 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI). Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies: * Study group: reduced stent PCI strategy (DCB-based) * Control group: conventional PCI strategy (DES-based).


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • \- Patients presenting with STEMI and indication to undergo pPCI.

Exclusion Criteria11

  • Life expectancy <1 year due 1 to non-cardiac disease.
  • Inability to provide informed consent.
  • Cardiogenic shock.
  • Left ventricular ejection fraction <15%.
  • Left main disease.
  • Stent thrombosis
  • Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).
  • Patients with chronic total occlusions.
  • Untreatable coronary disease.
  • Non-identified culprit lesion.
  • Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.

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Interventions

DEVICEPrimary PCI

Coronary percutaneous revascularization


Locations(15)

Hospital Universitario Y Politecnico La Fe

Valencia, Valencia, Spain

Consorcio Hospitalario Provincial de Castellon

Castelló, Spain

Hospital General Universitario de Elche

Elche, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Hospital Universitario Regional de Malaga

Málaga, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari Joan Xxiii de Tarragona

Tarragona, Spain

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

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